Efficacy and Safety Study of Neu2000KWL for Acute Ischemic Stroke Patients Within 6 Hours of Onset (Salfaprodil)
A Phase II, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of the Salfaprodil for Injection in Patients With Acute Ischemic Stroke
Sponsor: Beijing Tiantan Hospital
Listed as NCT04486430, this PHASE2 trial focuses on Cerebral Infarction and Stroke and remains completed. Sponsored by Beijing Tiantan Hospital, it has been updated 7 times since 2017, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)The present study is to investigate safety and efficacy of Neu2000, a multi-target neuroprotectant acting as a moderate NR2B-selective NMDA receptor antagonist and potent antioxidant, in acute ischemic stroke patients within 6 hours of onset. Compared to NMDA antagonists or antioxidants, improved efficacy and therapeutic time window of Neu2000 have been well documented in four animal models of stroke. Notable Safety of Neu2000 has been demonstrated in 168 human subjects conducted in the US and China as well as animals.
In the present phase II study, patients with acute ischemic stroke within 6 hours of onset would be assigned randomly to one of four groups as follows:
* Group A receiving 2.75g Neu2000KWL for 5 days
* Group B receiving 5.25g Neu2000KWL for 5 days
* Group C receiving 6.00g Neu2000KWL for 5 days
* Group D receiving placebo for 5 days
Patients will receive intravenous infusion of the clinical study drug twice a day at 12±1 hour intervals for 5 days.
The present study is to investigate safety and efficacy of Neu2000, a multi-target neuroprotectant acting as a moderate NR2B-selective NMDA receptor antagonist and potent antioxidant, in acute ischemic stroke patients within 6 hours of onset. Compared to NMDA antagonists or antioxidants, improved efficacy and therapeutic time window of Neu2000 have been well documented in four animal models of stroke. Notable Safety of Neu2000 has been demonstrated in 168 human subjects conducted in the US and China as well as animals.
In the present phase II study, patients with acute ischemic stroke within 6 hours of onset would be assigned randomly to one of four groups as follows:
* Group A receiving 2.75g Neu2000KWL for 5 days * Group B receiving 5.25g Neu2000KWL for 5 days * Group C receiving 6.00g Neu2000KWL for 5 days * Group D receiving placebo for 5 days
Patients will receive intravenous infusion of the clinical study drug twice a day at 12±1 hour intervals for 5 days.
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
-
Sep 2024 — Present [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jul 2023 — Jul 2024 [monthly]
Completed PHASE2
-
Oct 2021 — Jul 2023 [monthly]
Completed PHASE2
▶ Show 2 earlier versions
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Jan 2021 — Oct 2021 [monthly]
Completed PHASE2
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Aug 2020 — Jan 2021 [monthly]
Completed PHASE2
First recorded
Mar 2017
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Beijing Tiantan Hospital
- Daqing Oil Field Hospital
- First Affiliated Hospital of Jinan University
- First Affiliated Hospital of Wenzhou Medical University
- First Affiliated Hospital of Zhejiang University
- First Hospital of China Medical University
- General Hospital of Shenyang Military Region
- Guangzhou First People's Hospital
- Hebei General Hospital
- Hebei Medical University Third Hospital
- Inner Mongolia Baogang Hospital
- Nanfang Hospital, Southern Medical University
- Nanjing PLA General Hospital
- Peking University First Hospital
- Peking University Third Hospital
- Qilu Hospital of Shandong University
- Second Affiliated Hospital of Guangzhou Medical University
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Second Hospital of Shanxi Medical University
- Shandong Provincial Hospital
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Shanghai Minhang Central Hospital
- Shanghai Pudong New Area People's Hospital
- Subei People's Hospital of Jiangsu Province
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- The Central Hospital of Lishui City
- The First Affiliated Hospital of BaoTou Medical College
- The First Affiliated Hospital of Soochow University
- The First Hospital of Jilin University
- The Second Hospital of Hebei Medical University
- Tianjin First Central Hospital
- Tianjin Huanhu Hospital
- Tongji Hospital
- Xiangya Hospital of Central South University
- Xuanwu Hospital, Beijing
- Zhejiang Apeloa Jiayuan Pharmaceutical Co. Ltd.
For direct contact, visit the study record on ClinicalTrials.gov .